A company is looking for a Senior Clinical Regulatory Specialist. ...
Participate in the preparation and review of regulatory submissions to the US FDA and international (outside the US) regulatory authorities. Participate in the development of regional regulatory strategy and update strategy based on regulatory changes. A minimum of 5 years of experience in medical d...
A company is looking for a Regulatory Specialist in the US. ...
The Regulatory Affairs Specialist- Contractor will assist or lead a variety of regulatory tasks in support of global. Perform regulatory assessments for product changes including regulatory reportability decisions. Work with cross functional team and international regulatory colleagues to develop an...
Key Responsibilities:Plan, coordinate, and drive the development and evaluation of regulatory strategies and submissionsManage resources and provide regulatory leadership and mentoringConduct quality audits, develop management systems, and represent projects at various meetingsRequired Qualification...
The Staff/Principal Regulatory Affairs Specialist will function as a subject matter expert and will be part of a high-performing RA team and responsible for contributing to the development of regulatory strategies, preparing U. Represent regulatory in clinical program teams and communicate regulator...
The Principal Regulatory Affairs Specialist hired will report to the Senior Director of Regulatory and Quality, with sights to build out an RA team as needed. Support and prepare all regulatory submissions for FDA, Health Canada, Notified Bodies, and other regulatory agencies, with limited guidance ...
Our client, a large healthcare company is seeking a Regulatory Affairs Specialist to join their team! As the Regulatory Affairs Specialist you would provide regulatory support and expertise by developing global regulatory strategies, identifying needed registration data, obtaining this data and ensu...
We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry. Regulatory Affairs Specialist– Santa Clara, CA. Assi...
Participate in the preparation and review of regulatory submissions to the US FDA and international (outside the US) regulatory authorities. Participate in the development of regional regulatory strategy and update strategy based on regulatory changes. A minimum of 5 years of experience in medical d...
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs.Ardelyx has two commercial products approved in the United States, IBSRELA®(tenapanor) and XPHOZAH® (tenapanor), as well as early-stage pipeline ca...
We are currently seeking a highly motivated Regulatory Affairs Specialist to join our Regulatory Affairs department. Qualified individuals will be responsible for collection and coordination of regulatory documentation for submission to regulatory and business partners. Assist with the collection, c...
With 5-8 years of experience, you possess deep professional know-how and experience in regulatory affairs. Candidates have a mastery of regulatory guidance documents and requirements for FDA 510(k) submissions, Health license applications, and EU MDR technical files. Candidate expertise includes det...
Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps...
As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. Senior Regulatory Affairs Specialist. Assist in the development of regional regulatory strate...
The Sr Regulatory Affairs Specialist is responsible for ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier. Provides regulatory guidance and defines regulatory strategy for digital products...
Senior Regulatory Affairs Specialist (Multiple Positions), Becton Dickinson and Company, Milpitas, CA. Apply deep understanding of global regulatory landscape to analyze and compile country-specific regulatory requirements. Participating in setting regulatory operation process, including the regulat...
Senior Regulatory Affairs Specialist . Senior Regulatory Affairs Specialist. Provides regulatory input and technical guidance on global regulatory requirements to product development teams. Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team. ...
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs.Ardelyx has two commercial products approved in the United States, IBSRELA®(tenapanor) and XPHOZAH® (tenapanor), as well as early-stage pipeline ca...
We are currently seeking a highly motivated Regulatory Affairs Specialist to join our Regulatory Affairs department. Qualified individuals will be responsible for collection and coordination of regulatory documentation for submission to regulatory and business partners. Assist with the collection, c...
ERM has an opportunity for an experienced biologist/regulatory specialist to join our thriving global consulting firm as a . Principal Biologist/Regulatory Specialist. Principal Biologist/Regulatory Specialist. Serve as Project Biologist/Regulatory Specialist for environmental impact assessment unde...
Responsibilities also include keeping senior management informed of regulatory status of products and significant regulatory issues as well as maintain proficiency in global regulatory requirements. Principal Regulatory Affairs Specialist. Proven expertise in all aspects of Regulatory Affairs; Strat...
Regulatory Affairs Specialist will be working to build best in class products. The ideal candidate will have experience building a regulatory strategy and supporting documents from scratch, including developing, leading, and driving proactive execution of a global regulatory strategy. Acts as a regu...
Regulatory Affairs Specialist II. Regulatory Affairs Specialist II:. Regulatory Affairs Specialist II:. Works in close collaboration with internal customers and supports multiple projects to align on regulatory strategy to achieve business objectives. ...
In this role, you will… Perform regulatory assessments for product changes including regulatory reportability decisions Work with cross functional team and international regulatory colleagues to develop and implement global regulatory strategy to support business global expansions Support regulatory...